methocarbamol

Generic: methocarbamol

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methocarbamol
Generic Name methocarbamol
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

methocarbamol 100 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-317
Product ID 68083-317_36c2242f-82d7-4faa-a640-0a6e269038ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211504
Listing Expiration 2026-12-31
Marketing Start 2018-11-01

Pharmacologic Class

Established (EPC)
muscle relaxant [epc]
Physiologic Effect
centrally-mediated muscle relaxation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083317
Hyphenated Format 68083-317

Supplemental Identifiers

RxCUI
238175
UNII
125OD7737X
NUI
N0000175730 N0000175737

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methocarbamol (source: ndc)
Generic Name methocarbamol (source: ndc)
Application Number ANDA211504 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68083-317-25) / 10 mL in 1 VIAL (68083-317-01)
source: ndc

Packages (1)

68083-317-25 25 VIAL in 1 CARTON (68083-317-25) / 10 mL in 1 VIAL (68083-317-01)

Ingredients (1)

methocarbamol (100 mg/mL)

Linked Drug Pages (1)

Methocarbamol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "36c2242f-82d7-4faa-a640-0a6e269038ff", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["125OD7737X"], "rxcui": ["238175"], "spl_set_id": ["44c7fe99-8999-4747-9376-f13d3f9e5688"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68083-317-25)  / 10 mL in 1 VIAL (68083-317-01)", "package_ndc": "68083-317-25", "marketing_start_date": "20181101"}], "brand_name": "Methocarbamol", "product_id": "68083-317_36c2242f-82d7-4faa-a640-0a6e269038ff", "dosage_form": "INJECTION", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "68083-317", "generic_name": "Methocarbamol", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methocarbamol", "active_ingredients": [{"name": "METHOCARBAMOL", "strength": "100 mg/mL"}], "application_number": "ANDA211504", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}